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Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Failure; Mesenchymal Stem Cells

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Zhi-liang Gao, Dr, Study Director, Affiliation: Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China

Summary

The study aimed to investigate the short-term efficacy and long-term prognosis of liver failure patients caused by hepatitis B after single transplantation with autologous marrow mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited and received the same medical treatments, among whom some patients underwent single transplantation with autologous MMSCs and other patients with matched age, gender and biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group. A total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs suspension were slowly transfused into the liver through the proper hepatic artery by interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in translation group were compared with those in control group. In 3 ~ 48 months of follow-up, differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and mortality between two groups were compared.

Clinical Details

Official title: Therapeutic Effects Including Short-term Changes And Long-term Outcomes of Liver Failure Patients Caused by Chronic Hepatitis B After Single Transplantation With Autologous Bone Marrow Mesenchymal Stem Cells.

Study design: Observational Model: Case Control, Time Perspective: Retrospective

Primary outcome: Short-term therapeutic effects of transplantation.

Secondary outcome: Long-term outcomes of transplantation.

Detailed description: A total of 527 patients with chronic hepatitis B induced liver failure were recruited from May 2005 to June 2009 from our department. The diagnoses of chronic hepatitis B and liver failure were based on previously described criteria. All patients received the same medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin). Informed consent was obtained before study. Among these patients, 53 received transplantation with autologous MMSCs. The day of surgery served as the first day of observation. And 105 patients with matched age, gender and some biochemical indexes (ALT, ALB, TBIL, PT and MELD ) were served as controls.

Eligibility

Minimum age: 15 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Liver failure

Exclusion Criteria:

- HBV negative

Locations and Contacts

The Third Affiliated Hospital Of Sun Yat-sen University, Guangzhou, Guangdong 510630, China
Additional Information

Starting date: May 2005
Last updated: December 6, 2010

Page last updated: August 23, 2015

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